NCT06898970

Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma

An Open-Label, Multicenter, Phase 2 Study With Safety Lead-In of Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab in Patients With Angiosarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Varun Monga, MBBS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label study of Intratumoral Vusolimogene Oderparepvec (VO) to investigate safety and estimate when used in combination with pembrolizumab for treating participants with angiosarcoma. This is the first study evaluating this novel combination in participants with advanced angiosarcoma who have progressed after prior immunotherapy.

Detailed description

Primary Objectives: Safety Lead-in: I. To assess the safety and tolerability of VO in combination with pembrolizumab. Phase 2: 1. To assess the efficacy of VO in combination with pembrolizumab as determined by objective response rate (ORR). 2. To assess the safety and tolerability of VO in combination with pembrolizumab. Secondary Objectives: 1. To assess the duration of response (DOR). 2. To assess the complete response rate (CRR), clinical benefit rate (CBR), progression free survival, and 1-year and 2-year overall survival (OS). 3. To further assess the efficacy of VO in combination with pembrolizumab as determined by objective response rate (ORR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 OUTLINE: Participants may continue study treatment for up to 2 years with pembrolizumab and 24 weeks with VO. Some participants may be eligible to receive treatment after progression. For participants who discontinued for reasons other than confirmed progressive disease (PD) or completed treatment, tumor response assessments will continue approximately every 12 weeks from the last tumor assessment for up to two years or until the start of subsequent anticancer treatment, confirmed disease progression, withdrawal of consent, loss to follow-up, death, whichever occurs first. Participants will also be followed-up every 6 months to assess for survival/disease/anti-cancer therapy status for up to 2 years

Conditions

• Angiosarcoma
• Angiosarcoma, Adult

Interventions

Type	Name	Description
BIOLOGICAL	Vusolimogene Oderparepvec (VO)	Given intratumorally
DRUG	Pembrolizumab	Given IV

Timeline

• Start date: 2026-01-09
• Primary completion: 2029-10-31
• Completion: 2029-10-31
• First posted: 2025-03-27
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study